Latest news with #Pasithea
Winnipeg Free Press
17-05-2025
- Winnipeg Free Press
The Athenaeum is a green oasis in sun-soaked Athens
In Athens' white-washed, sun-baked urban-scape, The Athenaeum is a beacon of green freshness. After all, 2,500 plants drip from the face of the newest 5-star hotel in the Greek capital. The greenery grows in irrigated planters attached to an exoskeleton on the conveniently-located, seven-storey, white building — a short walk from the National Gardens, the touristy Plaka neighbourhood of shops and restaurants and the iconic Acropolis. The Athenaeum / Supplied The Pasithea rooftop bar and restaurant has views of the Acropolis, the Temple of Zeus and Mount Lycabettus. We'll be constantly surprised at The Athenaeum's lavishness — and simplicity. The lobby of the 52-room boutique hotel is minimalist and artsy with marble floors, white walls, two check-in counters that double as big cubes of abstract art and a huge monitor behind the check-in projecting constantly changing art. The first thing we notice when we step into our deluxe suite on the fifth floor is the purple-and-gold swing chair hanging from the ceiling. It's a whimsical instalment we absolutely have to test drive multiple times. The room itself is minimalist chic, with hardwood floors and king-size bed in white linens oriented to the soundproof, floor-to-ceiling windows with views over the National Garden to peek-a-boo glimpses of the Temple of Zeus, Acropolis and Mount Lycabettus. The Athenaeum / Supplied The 52-room hotel's entrance and lobby. The bathroom is Dionysos marble with a hydro-massage bathtub and separate rain shower. Our suite has handy proximity to the rooftop plunge pool and Pasithea restaurant, both of which also capitalize on the aforementioned views. At Pasithea we indulge in Greek dishes with a twist — chef Evangelos Nikas's red pepper oil tzatziki and shrimp in saffron sauce with Greek rosé wine from Chateau Nico Lazaridi. The Athenaeum is named after the building sacred to Athena, the Greek goddess of war and wisdom and the patroness of Athens. How apropos. Old Tavern of Psarras / Supplied The Old Tavern of Psarras has been serving up delicious food in Plaka since 1898. While The Athenaeum is a destination in itself, Athens, the city, beckons. So, we start to wander the historic capital — the birthplace of classical civilization — without an agenda. You don't really need an agenda to savour buzzy Athens. First, swing by Syntagma Square to see the hourly changing of the presidential guards in front of the parliament buildings and the Tomb of the Unknown Soldier. It's a spectacle as the Evzones guards march and prance their way through the exercise wearing a kilt-like tunic, tasselled Farion cap, stockings and shoes with pom poms and brandishing a M1 Garrand rifle. Steve MacNaull / Free Press The seven-storey facade of The Athenaeum boasts 2,500 plants. The seminal and emblematic Acropolis seems to have a gravitational pull, so we automatically start to walk there. It's because the can't-miss Acropolis is the highest hill in the centre of Athens and is crowned with the ruins of the instantly recognizable 2,472-year-old Parthenon. We simply admired it, eyes skyward, from every angle as we circumnavigated the Acropolis through the hillside neighbourhood of Plaka. Of course, you can be more organized and pre-book tickets to get past the gates at the Acropolis to visit and hear the blow-by-blow history of the Parthenon. But Kerry and I prefer to freestyle it, soaking up maximum vibe with a minimum of historical facts and dates. The Athenaeum / Supplied A junior suite at The Athenaeum. Plaka is village-like with its narrow cobblestone streets and stairways lined with shops and authentic Greek tavernas spilling down steps. Winnipeg Jets Game Days On Winnipeg Jets game days, hockey writers Mike McIntyre and Ken Wiebe send news, notes and quotes from the morning skate, as well as injury updates and lineup decisions. Arrives a few hours prior to puck drop. Although it's a tourist trap, it doesn't feel like it when we stop at The Old Tavern of Psarras — the oldest restaurant in Plaka, dating from 1898. Its tables are tiered down wide steps for perfect Plaka atmosphere, city views, people watching and, of course, traditional Greek food and wine. Think tzatziki with crusty bread, Greek salad with shiny, plump black olives, fried calamari and dolmades (stuffed grape leaves) washed down with local white wine Orinos Helios Semeli. For more info, check out Steve MacNaull / Free Press The ruins of the Parthenon temple atop the Acropolis is Athens' most emblematic attraction. smacnaull@ Steve MacNaull / Free Press Take in the changing of the guard near the Tomb of the Unknown Soldier in front of the Greek parliament. Steve MacNaull / Free Press The Pasithea restaurant features five neon-lit statues, including Discobolus (the Greek discus thrower). Steve MacNaull / Free Press A swing chair in The Athenaeum's deluxe suite is a whimsical touch.
Globe and Mail
14-05-2025
- Business
- Globe and Mail
Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site
-- First patient expected to be dosed during Q2 2025 -- -- Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas -- -- Starting dose of 4mg tablet QD (once daily) -- -- First trial site in Australia. Four additional sites planned for Australia, South Korea, and U.S. – -- Australian R&D Tax Incentive refund of up to 48.5% of eligible study-related costs expected -- MIAMI, May 14, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ('Pasithea' or the 'Company'), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced initiation of its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The study will also assess preliminary anti-tumor activity and help determine a recommended dose for subsequent Phase 2 trials. Exploratory objectives include assessing the effects of PAS-004 on cutaneous neurofibromas. The first active clinical trial site is the Royal North Shore Hospital in Sydney, Australia, which is expected to begin patient enrollment in Q2 2025. Additional clinical trial sites in Australia, South Korea, and the United States are expected to be opened in the coming months. Pasithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for this trial. The Company is conducting the study through its wholly owned subsidiary in Australia, Pasithea MacroMEK Pty Ltd, and anticipates eligibility for an Australian R&D Tax Incentive with a cash refund of up to 48.5% of the amount spent annually on eligible R&D activities (trial costs) in Australia. Dr. Rebecca Brown, M.D., Ph.D. a member of Pasithea's Scientific Advisory Board and Associate Professor of Neuro Oncology at The University of Alabama at Birmingham commented, 'I am pleased to have collaborated with the Pasithea team on the design of a comprehensive dose exploration and expansion study to assess the safety and tolerability of PAS-004 in adult NF1 patients. In addition to testing the effects of PAS-004 on plexiform neurofibromas, exploratory endpoints will also examine the effects of PAS-004 on cutaneous neurofibromas. The safety profile observed to date in advanced cancer patients is encouraging, and I look forward to seeing that profile translate to the NF1 population.' Dr. Brown added, 'One of the biggest challenges in treating plexiform neurofibromas associated with NF1 is ensuring that patients remain on MEK inhibitor therapy over the long-term. Real-world data shows that a significant proportion of NF1 patients discontinue treatment due to poor tolerability, including high rates of rash and gastrointestinal side effects. PAS-004 is also given as a once daily dose that offers a more convenient regimen than current FDA-approved therapies that are dosed twice a day and which could improve patient compliance.' Dr. Tiago Reis Marques, Pasithea's Chief Executive Officer, said, 'Following our recent financing, including the exercise of certain warrants, Pasithea is now funded to produce initial interim patient data in NF1. The initiation of this clinical trial in NF1, the initial indication we seek FDA marketing approval for, marks an important milestone for Pasithea and for patients living with NF1-related plexiform neurofibromas. Activating our first clinical trial site underscores our commitment to advancing PAS-004 as a potential best-in-class next-generation MEK inhibitor. We are encouraged by the safety and clinical data observed to date in oncology patients and are optimistic that PAS-004's tolerability profile will extend to the NF1 population. Importantly, our existing cancer data has enabled us to begin the NF1 trial at a higher dose than originally contemplated. In addition, we anticipate meaningful cash rebates of eligible trial costs through the Australian R&D Tax Incentive, further enhancing the efficiency of this program.' About the Phase 1/1b Clinical Trial in Adult NF1 Patients The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose ('RPBD') or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ('QOL') and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology. The trial will be conducted in two parts. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B, up to 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D). The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S. To learn more about the PAS-004 clinical trial in adults with NF1-associated plexiform neurofibromas, please visit About Pasithea Therapeutics Corp. Pasithea is a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, RASopathies and MAPK pathway driven tumors. Forward-Looking Statements This press release contains statements that constitute 'forward-looking statements' made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company's ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company's Phase 1/1b clinical trial of PAS-004 in adult patients with NF1-associated plexiform neurofibromas, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company's current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company's plans, assumptions, expectations, beliefs and objectives, the success of the Company's current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law. Pasithea Therapeutics Contact
Yahoo
14-05-2025
- Business
- Yahoo
Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site
-- First patient expected to be dosed during Q2 2025 ---- Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas ---- Starting dose of 4mg tablet QD (once daily) ---- First trial site in Australia. Four additional sites planned for Australia, South Korea, and U.S. –-- Australian R&D Tax Incentive refund of up to 48.5% of eligible study-related costs expected -- MIAMI, May 14, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ('Pasithea' or the 'Company'), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced initiation of its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The study will also assess preliminary anti-tumor activity and help determine a recommended dose for subsequent Phase 2 trials. Exploratory objectives include assessing the effects of PAS-004 on cutaneous neurofibromas. The first active clinical trial site is the Royal North Shore Hospital in Sydney, Australia, which is expected to begin patient enrollment in Q2 2025. Additional clinical trial sites in Australia, South Korea, and the United States are expected to be opened in the coming months. Pasithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for this trial. The Company is conducting the study through its wholly owned subsidiary in Australia, Pasithea MacroMEK Pty Ltd, and anticipates eligibility for an Australian R&D Tax Incentive with a cash refund of up to 48.5% of the amount spent annually on eligible R&D activities (trial costs) in Australia. Dr. Rebecca Brown, M.D., Ph.D. a member of Pasithea's Scientific Advisory Board and Associate Professor of Neuro Oncology at The University of Alabama at Birmingham commented, 'I am pleased to have collaborated with the Pasithea team on the design of a comprehensive dose exploration and expansion study to assess the safety and tolerability of PAS-004 in adult NF1 patients. In addition to testing the effects of PAS-004 on plexiform neurofibromas, exploratory endpoints will also examine the effects of PAS-004 on cutaneous neurofibromas. The safety profile observed to date in advanced cancer patients is encouraging, and I look forward to seeing that profile translate to the NF1 population.' Dr. Brown added, 'One of the biggest challenges in treating plexiform neurofibromas associated with NF1 is ensuring that patients remain on MEK inhibitor therapy over the long-term. Real-world data shows that a significant proportion of NF1 patients discontinue treatment due to poor tolerability, including high rates of rash and gastrointestinal side effects. PAS-004 is also given as a once daily dose that offers a more convenient regimen than current FDA-approved therapies that are dosed twice a day and which could improve patient compliance.' Dr. Tiago Reis Marques, Pasithea's Chief Executive Officer, said, 'Following our recent financing, including the exercise of certain warrants, Pasithea is now funded to produce initial interim patient data in NF1. The initiation of this clinical trial in NF1, the initial indication we seek FDA marketing approval for, marks an important milestone for Pasithea and for patients living with NF1-related plexiform neurofibromas. Activating our first clinical trial site underscores our commitment to advancing PAS-004 as a potential best-in-class next-generation MEK inhibitor. We are encouraged by the safety and clinical data observed to date in oncology patients and are optimistic that PAS-004's tolerability profile will extend to the NF1 population. Importantly, our existing cancer data has enabled us to begin the NF1 trial at a higher dose than originally contemplated. In addition, we anticipate meaningful cash rebates of eligible trial costs through the Australian R&D Tax Incentive, further enhancing the efficiency of this program.' About the Phase 1/1b Clinical Trial in Adult NF1 Patients The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose ('RPBD') or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ('QOL') and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology. The trial will be conducted in two parts. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B, up to 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D). The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S. To learn more about the PAS-004 clinical trial in adults with NF1-associated plexiform neurofibromas, please visit About Pasithea Therapeutics Corp. Pasithea is a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, RASopathies and MAPK pathway driven tumors. Forward-Looking Statements This press release contains statements that constitute 'forward-looking statements' made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company's ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company's Phase 1/1b clinical trial of PAS-004 in adult patients with NF1-associated plexiform neurofibromas, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company's current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company's plans, assumptions, expectations, beliefs and objectives, the success of the Company's current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law. Pasithea Therapeutics Contact Patrick GaynesCorporate Communicationspgaynes@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
